Pharmaceutical, Biotechnology, and Biopharmaceutical Clients

Contract Research

• Pre-Clinical
  We will help the client identify appropriate contract research organization(s) to carry out target identification, target validation, safety, and / or efficacy studies. These could include the use of either in vitro or in vivo models, or both.
  
  We will facilitate and recommend appropriate study design(s) to accommodate various budgets, monitor the progress of the study, assist in the interpretation of the results including statistical review, and assist in the preparation of the final study report.
  
  
• Clinical
  We will help the client identify appropriate clinical research organizations to carry out pharmacokinetic (Phase 1) and / or proof of concept / efficacy (Phase 2A / 2B) studies.
  
  We will facilitate and recommend appropriate study design(s) to accommodate various budgets, monitor the progress of the study, assist in the interpretation of the results including statistical review, and assist in the preparation of the final study report.

Drug Development

Cellular Models, Animal Models, Mechanism of Action

We will help the client identify appropriate cellular and animal models to carry out proof of concept, safety, and / or efficacy studies. These could include the use of either in vitro or in vivo models, or both. In addition, we will help the client identify appropriate cellular and animal models and study designs to identify the mechanism, or at least the mode of action of their lead compound(s).

Project Management

We provide comprehensive project management services; this service is included for all projects in which we are the primary consultant. We also offer comprehensive project management services for your on-going projects.

Technical Writing

• Scientific
  We provide a comprehensive panel of scientific writing services including the preparation of manuscripts containing original research data (pre-clinical and clinical), review articles, book chapters, meeting reports, posters, and PowerPoint® slide content.
  
  
• Drug Development
  We provide a comprehensive panel of pre-clinical technical writing services including the preparation of animal use protocols, internal study reports, PowerPoint® slide content, and reports to support Investigational New Drug filings.
• Business Development / Marketing
  We provide a comprehensive panel of technical writing services to support business development / out-licensing activities including the preparation abbreviated study reports, data organization and presentation, PowerPoint® slide content, and preparation of due diligence binders for prospective licensors.
  
  We provide a comprehensive panel of technical writing services to support marketing activities including the preparation of technology fact sheets and website content.
  
  
• Grant Applications
  We provide a comprehensive panel of grant writing services including the preparation and oversight of SBIR and STTR grant applications.

Technology Evaluation

We provide expert opinion and advice in the areas of technology evaluation / due diligence prior to in-licensing. Our focus is on type 2 diabetes and obesity targeted technology. We will perform a comprehensive document review including examination and critique of pre-clinical and clinical (if available) data, and prepare a written opinion (typically a 2-3 page report) as to the potential for success for the approach(es).